Document text
Page 1 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989312
Page 2 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/10/2020
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989313
Page 3 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12051077]
2.Birth Date: 1979
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989314
Page 4 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989315
Page 5 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989316
Page 6 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathNov/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989317
Page 7 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Subject had a lump on the neck]
Start Date: Jul/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Subject had a shortness of breath complaints]
Start Date: Jul/UNK/2020
Ongoing: YES
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989318
Page 8 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989319
Page 9 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
2.Weight: [107.0]
3.Unit: kg
4.Height: [185.0]
5.Unit: cm
6.Body Mass Index: [31.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989320
Page 10 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/10/2020
2.Randomization Number: [116063]
3.Randomization Group: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989321
Page 11 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDH56]
5.bSample ID [BRDH57]
5.cSample ID [BSHR31]
5.dSample ID [BSHR32]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989322
Page 12 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDH50]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989323
Page 13 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/10/2020 15:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989324
Page 14 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989325
Page 15 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989326
Page 16 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989327
Page 17 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989328
Page 18 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989329
Page 19 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989330
Page 20 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5PLR]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989331
Page 21 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/2/2020 11:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989332
Page 22 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989333
Page 23 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989334
Page 24 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989335
Page 25 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989336
Page 26 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8X97]
5.bSample ID [BN8X98]
5.cSample ID [BNM4VM]
5.dSample ID [BNM4VN]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989337
Page 27 of 183
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989338
Page 28 of 183
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989339
Page 29 of 183
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989340
Page 30 of 183
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989341
Page 31 of 183
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989342
Page 32 of 183
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989343
Page 33 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989344
Page 34 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989345
Page 35 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989346
Page 36 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989347
Page 37 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989348
Page 38 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989349
Page 39 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989350
Page 40 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989351
Page 41 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989352
Page 42 of 183
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989353
Page 43 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Nasal Septum
Deviation Jan/19/2021
UNK:UNK NO
End Date Time:
Jan/20/2021 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Encapsulated
Lipoma Jan/19/2021
UNK:UNK NO
End Date Time:
Jan/20/2021 UNK:
UNK
Repeating
Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989354
Page 44 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Nasal Septum Deviation]
4.Start Date Time: Jan/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989355
Page 45 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Deviated Septum Operation was performed on 19Jan21
due to Nasal Septum Deviation]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989356
Page 46 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021168918]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989357
Page 47 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Encapsulated Lipoma]
4.Start Date Time: Jan/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989358
Page 48 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Encapsulated lipoma excising operation was performed
on 19Jan21.]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989359
Page 49 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021139636]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989360
Page 50 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989361
Page 51 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989362
Page 52 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989363
Page 53 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989364
Page 54 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989365
Page 55 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989366
Page 56 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989367
Page 57 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989368
Page 58 of 183
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989369
Page 59 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989370
Page 60 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989371
Page 61 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989372
Page 62 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Dec/4/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER
PRESENT
3.Comments: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989373
Page 63 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989374
Page 64 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989375
Page 65 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989376
Page 66 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989377
Page 67 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989378
Page 68 of 183
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989379
Page 69 of 183
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989380
Page 70 of 183
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989381
Page 71 of 183
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989382
Page 72 of 183
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jan/6/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989383
Page 73 of 183
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989384
Page 74 of 183
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989385
Page 75 of 183
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989386
Page 76 of 183
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989387
Page 77 of 183
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989388
Page 78 of 183
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989389
Page 79 of 183
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/6/2021
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989390
Page 80 of 183
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989391
Page 81 of 183
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989392
Page 82 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-10-2020 17:05:06 (UTC+03:00)
IstanbulNot Applicable
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989393
Page 83 of 183
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-04-2021 13:54:09 (UTC+03:00)
IstanbulEdit - All
signatures
invalidated
Affidavit:
N/A
Serhat Unal Approved Feb-22-2021 13:43:11 (UTC+03:00)
IstanbulBOOK Signed
Affidavit:
By my dated signature below, I, SerhatUnal, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989394
Page 84 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-10-2020
17:01:43
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-10-2020
17:01:43
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989395
Page 85 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-10-2020
17:02:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Nov/10/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989396
Page 86 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-10-2020
17:01:30
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12051077Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Nov-10-2020
17:01:26
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1979Enrollment
Entry
3. Sex:
Date Location User Value Reason
Nov-10-2020
17:02:30
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-10-2020
17:02:30ACV0PFEINFP6000 Data Entry:
NOT HISPANIC ORInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0989397
Page 87 of 183
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulLATINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-10-2020
17:02:30
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989398
Page 88 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
17:04:52
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989399
Page 89 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-10-2020
17:07:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-10-2020
17:07:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-10-2020
17:07:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989400
Page 90 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-10-2020
17:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-10-2020
17:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-10-2020
17:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989401
Page 91 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.a Start Date:
Date Location User Value Reason
Nov-10-2020
17:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-10-2020
17:13:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Feb-19-2021
13:39:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History
Term:Subject had
a lump on t
he neck
Start Dat
e:Jul/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989402
Page 92 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Line/MH Number:
Date Location User Value Reason
Feb-19-2021
13:39:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021
13:39:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Subject had a lump
on the neckInitial Entry
1.b Start Date:
Date Location User Value Reason
Feb-19-2021
13:39:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jul/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Feb-19-2021
13:39:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989403
Page 93 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c
Date Location User Value Reason
Feb-19-2021
13:40:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:3
Medica
l Histor
y Term:Subject had a
shortness of
breath compl
aints
Start D
ate:Jul/UNK/202
0
Ongoin
g:YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989404
Page 94 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Feb-19-2021
13:40:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021
13:40:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Subject had a shortn
ess of breath compla
intsInitial Entry
1.c Start Date:
Date Location User Value Reason
Feb-19-2021
13:40:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jul/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Feb-19-2021
13:40:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989405
Page 95 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-10-2020
17:07:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989406
Page 96 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
107.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-10-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989407
Page 97 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:09:47
(UTC+03:00)
Istanbul185.0
5. Unit:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.3Initial Entry
7.a
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:36.2
Temperatur
e Unit:CInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989408
Page 98 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989409
Page 99 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
17:09:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989410
Page 100 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-10-2020
17:13:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-10-2020
17:13:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
116063Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989411
Page 101 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020
17:15:13
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020
17:15:13
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020
17:17:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-10-2020
17:15:13
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989412
Page 102 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Please review
and correct as
appropriate.
Nov-10-2020
17:15:13
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020
17:17:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample ID
:BRDH5
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020
17:17:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BRDH56Initial Entry
5.b
Date Location User Value Reason
Nov-10-2020
17:17:16
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
Sample ID BRDH5Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989413
Page 103 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul : 7
5.b Sample ID
Date Location User Value Reason
Nov-10-2020
17:17:16
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BRDH57Initial Entry
5.c
Date Location User Value Reason
Nov-10-2020
17:17:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample ID
:BSHR3
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-10-2020
17:17:47
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BSHR31Initial Entry
5.d
Date Location User Value Reason
Nov-10-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989414
Page 104 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:18:01
(UTC+03:00)
IstanbulSample ID
:BSHR3
2
5.d Sample ID
Date Location User Value Reason
Nov-10-2020
17:18:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BSHR32Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989415
Page 105 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020
17:14:20
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020
17:14:20
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020
17:14:57
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-10-2020
17:14:20
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989416
Page 106 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Please review
and correct as
appropriate.
Nov-10-2020
17:14:20
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020
17:14:57
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample ID
:BRDH5
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020
17:14:57
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BRDH50Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989417
Page 107 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-10-2020
17:10:46ACV0PFEINFP6000 Data Entry:
Nov/10/2020 15:20Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989418
Page 108 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbul
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-10-2020
17:10:46ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989419
Page 109 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-10-2020
17:10:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989420
Page 110 of 183
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-10-2020
17:12:04
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989421
Page 111 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-02-2020
10:53:24
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989422
Page 112 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989423
Page 113 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989424
Page 114 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989425
Page 115 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989426
Page 116 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.d Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989427
Page 117 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
2.e Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
ARInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989428
Page 118 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
O
2.f Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-02-2020
10:54:08ACV0PFEINFP6000 Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989429
Page 119 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulOR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989430
Page 120 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989431
Page 121 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989432
Page 122 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul
5.a
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989433
Page 123 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbul
5.b
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989434
Page 124 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989435
Page 125 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-02-2020
10:54:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989436
Page 126 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
2.a
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:36.2
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989437
Page 127 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Temperature:
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-02-2020
10:54:37
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989438
Page 128 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-02-2020
10:57:40
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-02-2020
10:57:40
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-02-2020
10:58:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-02-2020
10:57:40
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989439
Page 129 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Please review
and correct as
appropriate.
Dec-02-2020
10:57:40
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
5.a
Date Location User Value Reason
Dec-02-2020
10:58:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample ID
:BR5PL
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-02-2020
10:58:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BR5PLRInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989440
Page 130 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-02-2020
11:31:50ACV0PFEINFP6000 Data Entry:
Dec/2/2020 11:18Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989441
Page 131 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbul
5. Anatomical Location:
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-02-2020
11:31:50ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989442
Page 132 of 183
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Dec-02-2020
11:31:50
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989443
Page 133 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021
11:20:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989444
Page 134 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989445
Page 135 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989446
Page 136 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989447
Page 137 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989448
Page 138 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.d Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989449
Page 139 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
2.e Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
ARInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989450
Page 140 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
O
2.f Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-06-2021
11:21:46ACV0PFEINFP6000 Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989451
Page 141 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulOR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989452
Page 142 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989453
Page 143 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989454
Page 144 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul
5.a
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989455
Page 145 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbul
5.b
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989456
Page 146 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989457
Page 147 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-06-2021
11:21:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989458
Page 148 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021
11:22:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021
11:22:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021
11:22:24
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-06-2021
11:22:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989459
Page 149 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Please review
and correct as
appropriate.
Jan-06-2021
11:22:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021
11:22:24
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample ID
:BN8X9
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021
11:22:24
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BN8X97Initial Entry
5.b
Date Location User Value Reason
Jan-06-2021
11:22:40
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
Sample ID BN8X9Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989460
Page 150 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul : 8
5.b Sample ID
Date Location User Value Reason
Jan-06-2021
11:22:40
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BN8X98Initial Entry
5.c
Date Location User Value Reason
Jan-06-2021
11:23:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Sample I
D:BNM4V
MInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-06-2021
11:23:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BNM4VMInitial Entry
5.d
Date Location User Value Reason
Jan-06-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989461
Page 151 of 183
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11:23:34
(UTC+03:00)
IstanbulSample I
D:BNM4V
N
5.d Sample ID
Date Location User Value Reason
Jan-06-2021
11:23:34
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
BNM4VNInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0989462
Page 152 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989463
Page 153 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Form Created
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989464
Page 154 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021
23:42:30
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response
satisfies query
Feb-19-2021
13:42:33
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Answered Both
symptoms
were added on
MHx page of
Inform as
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989465
Page 155 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
separately.
Feb-16-2021
22:47:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Per
SAE report,
"the subject
had a lump on
the neck and
shortness of
breath
complaints for
6-7 months”.
Please add
those 2
symptoms
into MHx
module.
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Nasal Septum Devi
ationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/19/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989466
Page 156 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/20/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
17:54:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response
satisfies query
Mar-05-2021
16:54:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dNew
Information
Mar-05-2021
16:54:00
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2New
Information
Feb-28-2021
21:30:54
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: As
this AE led to
surgery and
hospitalization,
please
re-consider if
the AE grade
was 2.
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989467
Page 157 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-16-2021
22:54:11
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Closed Updated in SDB
Feb-16-2021
14:13:39
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Answer
edNasal Septum
Deviation and
Encapsulated
Lipoma serious
adverse events
were sent to the
safety report on
09.Feb.2021.
Feb-11-2021
11:55:56
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 2: Opened SAE
RECON:Nasal
Septum
Deviation(Onset
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989468
Page 158 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
date:19Jan2021)
is not reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE
CRF
Feb-11-2021
11:55:04
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Deleted Query can be
addressed
internally
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE Nasal
Septum
Deviation:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-09-2021
14:48:48ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989469
Page 159 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
IstanbulIs this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or sign
ificant disability
/incapacity?
NO
Is this serious e
vent life threate
ning?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989470
Page 160 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
Other medically
important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify
:
Deviated SeptInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989471
Page 161 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
um Operation
was performed
on 19Jan21 du
e to Nasal Sep
tum Deviation
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021
01:00:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response
satisfies query
Feb-22-2021
13:54:10ACV0PFEINFP6000 Query 1: Answere
dAn elective
procedure was
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989472
Page 162 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00)
Istanbulperformed for
this volunteer
as scheduling
of the
procedure.
Feb-19-2021
19:59:08
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:
OpenedSorry, not
clear. Was this
an elective
procedure?
Feb-19-2021
13:01:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dNew
Information
Feb-19-2021
13:01:01
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESNew
Information
Feb-16-2021
18:45:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened CLINICAL_
Per report, the
subject
underwent
surgery. Pls
clarify if this
was an elective
procedure.
Thanks
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989473
Page 163 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-09-2021
14:48:48
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021
11:39:10
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2021168918AER updated
Mar-04-2021
13:54:09
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2021139636updated to
matched SDB
Feb-19-2021
10:06:36
(UTC+03:00)ACV0PFEINFP6000 Data Entry:
2021168918new AER for
the event
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989474
Page 164 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Istanbul
Feb-15-2021
10:34:27
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2021139636Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989475
Page 165 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021
01:52:49
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed ok.
Mar-05-2021
17:07:45
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Answered Any timing
details have
not been
stated in
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989476
Page 166 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
report.
Mar-05-2021
01:13:38
(UTC+03:00)
IstanbulACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical
Monitor_ Pls
advice if at
any given
time the
subject had a
biopsy.
Thanks
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Encapsulated Lipo
maInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/19/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/20/2021 UN
K:UNKInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989477
Page 167 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
17:54:53
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response
satisfies query
Mar-05-2021
16:54:42
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dNew
Information
Mar-05-2021
16:54:42
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2New
Information
Feb-28-2021
21:31:38
(UTC+03:00)
IstanbulACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: As
this AE led to
surgery and
hospitalization,
please
re-consider if
the AE grade
was 2.
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989478
Page 168 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-11-2021
04:15:19
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eFor AE
Encapsulated
Lipoma :
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989479
Page 169 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or pr
olong hospitaliza
tion?
YES
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious ev
ent life threatenin
g?
NO
Other medically i
mportant serious
event
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989480
Page 170 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify
:
Encapsulated l
ipoma excisin
g operation wa
s performed o
n 19Jan21.Initial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989481
Page 171 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989482
Page 172 of 183
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-09-2021
14:54:35
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-11-2021
04:15:19
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
2021139636Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0989483
Page 173 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-04-2020
10:25:22
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Dec/4/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989484
Page 174 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Dec-04-2020
10:26:05
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-04-2020
10:25:31
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Dec-04-2020
10:25:31
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
CONTACT OUTC
OMEInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989485
Page 175 of 183
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Dec/04/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Dec-04-2020
10:26:05
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Dec-04-2020
10:26:05
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Dec/4/2020
Contact Outcome:
VISIT NOT AR
RANGED, REA
CTION NO LON
GER PRESENTInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989486
Page 176 of 183
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-06-2021
13:52:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-06-2021
13:52:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-06-2021
13:52:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989487
Page 177 of 183
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
14:07:46
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989488
Page 178 of 183
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-20-2021
11:29:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-20-2021
06:16:57
(UTC+03:00)
IstanbulACV0PFEINFP6000 Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-19-2021
14:32:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989489
Page 179 of 183
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
complete this
date.
Jan-19-2021
14:32:06
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have receive
d only placebo
at Vaccination
1/2Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989490
Page 180 of 183
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-20-2021
11:29:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021
11:29:03
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989491
Page 181 of 183
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-06-2021
13:52:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-10-2020
17:13:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Nov-10-2020
17:07:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-06-2021
13:52:29
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/6/2021Initial Entry
Nov-10-2020
17:13:55
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989492
Page 182 of 183
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
17:07:14
(UTC+03:00)
IstanbulACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989493
Page 183 of 183
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty
Subject No: 12051077 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-02-2020
14:55:32
(UTC+03:00)
IstanbulACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3f31\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989494